Evaluation of the Accuracy of an Implanted Glucose Sensor

Diabetes Mellitus Clinical Trial

— PRECISEII  

Official title:

A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647905
• Other study ID #: CTP-0023
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: May 2018
• Source: Senseonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult subjects, age =18 years

2. Clinically confirmed diagnosis of diabetes mellitus for =1 year

3. Subject has signed an informed consent form and is willing to comply with protocol requirements

Exclusion Criteria:

1. History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure

2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months

3. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for = 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.

4. A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.

5. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e,g, CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.

6. Hematocrit <30% or >55%

7. History of hepatitis B, hepatitis C, or HIV

8. Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitoring System
Accuracy and safety assessment of a continuous glucose monitoring device

Locations

Country	Name	City	State
United States	Atlanta Diabetes Care	Atlanta	Georgia
United States	UVA Diabetes and Endocrine Clinic	Charlottesville	Virginia
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	AMCR Institute	Escondido	California
United States	Mount Sinai Diabetes Center	New York	New York
United States	Rainier Clinical Research	Renton	Washington
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Worldwide Clinical Trials	San Antonio	Texas
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Senseonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CGM System Agreement With Reference Control	The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)	90 days
Primary	CGM Relative Difference to Laboratory Reference Reported as MARD	Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.	90 days